LibGuides: Pharmaceutical Sciences: Websites

The following websites are reliable and relevant to your program. Click on the button beside each website to view a description of what it offers.

Active Licenses for Medical Devices

Health Canada Medical Devices Active Licenses Search MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. This resource can be searched by company name or identifier, licence name or number, or device name or identifier.

Associations and Societies

Canadian Association of Professionals in Regulatory Affairs (CAPRA) An organization dedicated to providing its members with opportunities to enhance their professional development and maximize career opportunities, whether they are student, entry-level associates or experienced executives.
Canadian Society for Pharmaceutical Sciences (CSPS) A network of Canadian pharmaceutical scientists in pursuit of excellence in research, development, and training.
Drug Information Association (DIA) Members are life Sciences professionals, collaborating in order to create better policies, regulations, science, research and development.
Innovative Medicines Canada (IMC) Membership consists of 43 companies, from established organizations to fledgling startups, all of whom are revolutionizing healthcare through the discovery and development of new medicines and vaccines.
The Organization For Professionals in Regulatory Affairs (TOPRA) An international professional membership organization for individuals working in healthcare regulatory affairs to promote excellence across the healthcare regulatory profession.
The Regulatory Affairs Professionals Society (RAPS) The largest global organization of and for those involved with the regulation of healthcare and related products, including pharmaceuticals.

Drug Information

DailyMed DailyMed provides high quality information about marketed drugs, including FDA labels (package inserts).
Drug and Health Products Inspection Database (DHPID) This database provides information about each type of drug and health product inspection done by Health Canada in Canada and abroad since 2012 and identifies which health product establishments are licensed or registered by Health Canada.
Drug Bank A comprehensive database containing information on drugs and drug targets. Intended for educational and scientific research purposes only. Created by the University of Alberta.
Drug Digest A noncommercial, evidence-based, consumer health and drug information site dedicated to empowering consumers to make informed choices about drugs and treatment options.
Drug Product Database Search by drug identification number (DIN), Anatomical Therapeutic Chemical (ATC) code, company, or other product characteristics. Created by Health Canada.
Drugs.com Offers prescription and over-the-counter drug information for consumers and professionals.
Rxlist A drug index offering detailed and current pharmaceutical information for brand and generic drugs.

Guidelines & Standards

ICH Guidelines The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use aims to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. ICH Guidelines are developed / maintained via a process of scientific consensus with regulatory and industry experts working side-by-side

Guidance Documents

Government of Canada Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications Offers guidance to all sponsors seeking authorization to sell or import a drug for the purpose of a clinical trial in Canada
Government of Canada Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” Offers guidance to anyone conducting clinical drug trials using human subjects in Canada.
Government of Canada Guidance Document for Applications for Medical Device Investigational Testing Authorizations Offers guidance to manufacturers and importers in preparing the documentation necessary to obtain an authorization for the sale or importation of a medical device under an Investigational Testing Authorization (ITA), while assuring the protection of research subjects, and promoting excellence in research and development in Canada
Government of Canada Compliance and Enforcement Policy for Health Products Intended to facilitate compliance with the Food and Drugs Act and its regulations and applicable administrative policies.
Government of Canada Guide for Good Manufacturing Practices Guide for Drug Products Offers guidance to assist fabricators, packagers, labellers, testers, distributors, importers and wholesalers in complying with good manufacturing practices.

Patent Searching

Advanced Patent Searching for Chemical / Pharmaceutical Patents Created by Clemson University Libraries, this guide lists numerous sources for finding chemical and pharmaceutical patent information.

Product Suppliers

Sigma-Aldrich Vendor of biochemical and organic chemical products and kits for use in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease, and as key components in pharmaceutical and other high technology manufacturing.

Regulations

Canada's Food and Drugs Act Sets out requirements for the manufacture, packaging, labelling, storage, importation, distribution and sale of foods and prescription and non-prescription drugs in Canada.
Canada's Food and Drug Regulations Regulations made under Canada's Food and Drugs Act, including requirements for drug clinical trials.
Canada's Medical Devices Regulations Regulations setting out legal requirements for medical devices in Canada.
Canada's Natural Health Products Regulations Regulations setting out legal requirements for medical devices in Canada.

Regulatory Bodies

Health Canada Before drug products (prescription and non-prescription) are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality.
U.S. Food and Drug Administration (FDA) A federal agency of the Department of Health and Human Services, the FDA is responsible for the control and safety of dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines and biopharmaceuticals.
International Federation of Pharmaceutical Manufacturers Associations (IFPMA) This trade association represents pharmaceutical companies around the world, promoting policies that foster innovation, resilient regulatory systems and high standards of quality, upholding ethical practices, and advocating sustainable health policies to meet patient and health system needs.